Commission Directive 2011/18/EU (repealed)Show full title

ANNEX III

“ANNEX VI VERIFICATION PROCEDURE FOR SUBSYSTEMS

1. GENERAL PRINCIPLES

The verification procedure for a subsystem involves checking and certifying that a subsystem:

• is designed, constructed and installed in such a way as to meet the essential requirements concerning it, and

• may be authorised to be placed in service.

2. “EC” VERIFICATION PROCEDURE

2.1. Introduction

“EC” verification is the procedure whereby a notified body checks and certifies that the subsystem:

• complies with the relevant TSI(s),

• complies with the other regulations deriving from the Treaty.

2.2. Parts of the subsystem and stages

2.2.1 Intermediate statement of verification (ISV)

If specified in the TSIs or, where appropriate, at the applicant’s request, the subsystem could be divided into certain parts or checked at certain stages of the verification procedure.

The intermediate statement of verification (ISV) is the procedure whereby a notified body checks and certifies certain parts of the subsystem or certain stages of the verification procedure.

Each ISV leads to the issuing of an “EC” ISV certificate by the notified body chosen by the applicant, which in turn, where applicable, draws up an “EC” ISV declaration. The ISV certificate and ISV declaration must provide reference to the TSIs with which the conformity has been assessed.

2.2.2 Parts of the subsystem

The applicant may apply for an ISV for each part. And each part shall be checked at each stage as described in Section 2.2.3.

2.2.3 Stages of the verification procedure

The subsystem, or certain parts of the subsystem, shall be checked at each of the following stages:

• overall design,

• production: construction, including, in particular, civil-engineering activities, manufacturing, constituent assembly and overall adjustment,

• final testing.

The applicant may apply for an ISV for the design stage (including the type tests) and for the production stage.

2.3. Certificate of verification

2.3.1. The notified body responsible for “EC” verification assesses the design, production and final testing of the subsystem and draws up the “EC” certificate of verification intended for the applicant, who in turn draws up the “EC” declaration of verification. The “EC” verification certificate must provide reference to the TSIs with which the conformity has been assessed.

Where a subsystem has not been assessed for its conformity with all relevant TSI(s) (e.g. in the case of a derogation, partial application of TSIs for upgrade or renewal, transitional period in a TSI or specific case), the “EC” certificate shall give the precise reference to the TSI(s) or their parts whose conformity has not been examined by the notified body during the “EC” verification procedure.

2.3.2. Where “EC” ISV certificates have been issued the notified body responsible for the “EC” verification of the subsystem takes these “EC” ISV certificates into account, and, before issuing the “EC” certificate of verification, it:

• verifies that the “EC” ISV certificates cover correctly the relevant requirements of the TSI(s),

• checks all aspects that are not covered by the “EC” ISV certificate(s), and

• checks the final testing of the subsystem as a whole.

2.4. Technical file

The technical file accompanying the “EC” declaration of verification must contain the following:

• technical characteristics linked to the design including general and detailed drawings with respect to execution, electrical and hydraulic diagrams, control-circuit diagrams, description of data-processing and automatic systems, documentation on operation and maintenance, etc., relevant for the subsystem concerned,

• list of interoperability constituents, as referred to in Article 5(3)(d), incorporated into the subsystem,

• copies of the “EC” declarations of conformity or suitability for use with which the abovementioned constituents must be provided in accordance with Article 13 of the Directive, accompanied, where appropriate, by the corresponding calculation notes and a copy of the records of the tests and examinations carried out by the notified bodies on the basis of the common technical specifications,

• where available, the “EC” ISV certificate(s) and, in such a case, where relevant, the “EC” ISV declaration(s), that accompany the “EC” certificate of verification, including the result of verification by the notified body of the certificates validity,

• “EC” certificate of verification, accompanied by corresponding calculation notes and signed by the notified body responsible for the “EC” verification, stating that the subsystem complies with the requirements of the relevant TSI(s) and mentioning any reservations recorded during performance of the activities and not withdrawn; the “EC” certificate of verification should also be accompanied by the inspection and audit reports drawn up by the same body in connection with its task, as specified in Sections 2.5.3 and 2.5.4,

• “EC” certificates issued in accordance with other legislation deriving from the Treaty,

• when safe integration is required pursuant Commission Regulation (EC) No 352/2009(1), the applicant shall include in the technical file the assessor’s report on the Common Safety Methods (CSM) on risk assessment referred to in Article 6(3) of Directive 2004/49/EC.

2.5. Monitoring

2.5.1. The aim of “EC” monitoring is to ensure that the obligations deriving from the technical file have been met during the production of the subsystem.

2.5.2. The notified body responsible for checking production must have permanent access to building sites, production workshops, storage areas and, where appropriate, prefabrication or testing facilities and, more generally, to all premises which it considers necessary for its task. The notified body must receive from the applicant all the documents needed for that purpose and, in particular, the implementation plans and technical documentation concerning the subsystem.

2.5.3. The notified body responsible for checking implementation must periodically carry out audits in order to confirm compliance with the relevant TSI(s). It must provide those responsible for implementation with an audit report. Its presence may be required at certain stages of the building operations.

2.5.4. In addition, the notified body may pay unexpected visits to the worksite or to the production workshops. At the time of such visits the notified body may conduct complete or partial audits. It must provide those responsible for implementation with an inspection report and, if appropriate, an audit report.

2.5.5. With a view to delivering the “EC” declaration of suitability for use referred to in Section 2 of Annex IV, the notified body shall be able to monitor a subsystem on which an interoperability constituent is mounted in order to assess, where required by the corresponding TSI so requires, its suitability for use in its intended railway environment.

2.6. Submission

The complete file referred to in paragraph 2.4 must be lodged with the applicant in support of the “EC” ISV certificate(s), if available, issued by the notified body responsible for this or in support of the certificate of verification issued by the notified body responsible for “EC” verification of the subsystem. The file must be attached to the “EC” declaration of verification which the applicant sends to the competent authority with which he lodges the application for authorisation for placing in service.

A copy of the file must be kept by the applicant throughout the service life of the subsystem. It must be sent to any other Member States which so request.

2.7. Publication

Each notified body must periodically publish relevant information concerning:

• requests for “EC” verification and ISV received,

• request for assessment of conformity and/or suitability for use of ICs,

• “EC” ISV certificates issued or refused,

• “EC” certificates of conformity and/or suitability for use issued or refused,

• “EC” certificates of verification issued or refused.

2.8. Language

The files and correspondence relating to the “EC” verification procedures must be written in an EU official language of the Member State in which the applicant is established or in an EU official language accepted by the applicant.

3. VERIFICATION PROCEDURE IN THE CASE OF NATIONAL RULES

3.1. Introduction

The verification procedure in the case of national rules is the procedure whereby the body designated pursuant to Article 17(3) (the designated body) checks and certifies that the subsystem complies with the national rules notified in accordance with Article 17(3).

3.2. Certificate of verification

The designated body responsible for the verification procedure in the case of national rules draws up the certificate of verification intended for the applicant.

The certificate shall contain a precise reference to the national rule(s) whose conformity has been examined by the designated body in the verification process, including those related to parts subject to derogation from a TSI, upgrade or renewal.

In the case of national rules related to the subsystems composing a vehicle, the designated body shall divide the certificate into two parts, one part including the references to those national rules strictly related to the technical compatibility between the vehicle and the network concerned, and the other part for all other national rules.

3.3. Technical file

The technical file accompanying the certificate of verification in the case of national rules must be included in the technical file referred to in point 2.4 and shall contain the technical data relevant for the assessment of the conformity of the sub-system with the national rules.”

(1)

OJ L 108, 22.4.2009, p 4.